Opiate Withdrawal SyndromeMTH01NCT01945736
Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal
An observational study of Opiate Withdrawal Syndrome, run by Kevin Watt at 5 sites in United States.
Trial summary
The purpose of this study is to learn more about how the study drug, methadone, prescribed by an infant's or child's physician as part of standard medical care, is processed in children and young adults. Read more about this study
- Who is it for?
- Ages 91 days to 18 years
- Conditions the study is for
- Opiate Withdrawal Syndrome
- What is being tested?
- Methadone
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 91 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be divided into 3 groups based on age, ages 3 months to 2 years, ages 2 to 6 years, and ages 6 to 18 years. There will be approximately 8 to 12 participants enrolled in each group. Additionally, at least 6 overweight or obese participants between ages 2-18 years will be included in this study.
Who may be able to join
- >90 days - < 18 years of age at the time of first dose of study drug
- Receiving enteral methadone as standard of care
- Signed informed consent/HIPAA documents by the parent/legal guardian and assent (if applicable)
Who cannot join
- Previous participation in the study
- Subject is receiving ECLS (Extracorporeal Life Support)
- < 36 weeks gestational age at birth for children <1 year of age at time of enrollment
- Any other condition or chronic illness that in the opinion of the Principal
- Investigator makes participation unadvised or unsafe
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Medical University of South Carolina
Charleston, South Carolina, 29425
Duke University Medical Center
Durham, North Carolina, 27701
Children's Mercy Hospital
Kansas City, Kansas, 64108
All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: Pharmacokinetics of Multiple Dose Methadone in Children
The purpose of this study is to learn more about how the study drug, methadone, prescribed by an infant's or child's physician as part of standard medical care, is processed in children and young adults. While this drug is used extensively in infants and children, it has not been extensively studied in this population.
Physicians do not have very much information on how long it takes for methadone to be removed from the blood circulation and passed out of the body. Physicians need more information to guide how much and how often we should give methadone to children/young adults to ensure they get the maximum effect with the minimum amount of drug. During this research study, the study team will collect information about how this drug is processed in infants and children.
Read the detailed description
A total of approximately 24 to 36 infants and children will participate in this study. This study will be done at five medical centers in the United States.
Treatment will be prescribed by the infant or child's doctor and not by the study team.
Participants will be divided into 3 groups based on age, ages 3 months to 2 years, ages 2 to 6 years, and ages 6 to 18 years. There will be approximately 8 to 12 participants enrolled in each group. Additionally, at least 6 overweight or obese participants between ages 2-18 years will be included in this study.
Information collected from each subject's routine medical care will include:
- Participant gender, date of birth, race and ethnicity
- Pertinent medical history
- Laboratory results (blood count and chemistries) from routine testing ordered by the infant or child's regular doctor
- Medications of interest the child was given within the 72 hours prior to first dose of methadone administered after consent
- Time and dose of methadone administered to the child up to 14 days prior to enrollment
Study specific information collected will include:
- Blood sample collection to measure level of methadone
- Baseline WAT-1 score (sedation withdrawal assessment of the infant or child used to assess symptoms the child/infant may experience when opioid drugs are discontinued).
The duration of the study will be up to 10 days, comprised of a maximum 5 day treatment period a 5 day observation period.
- Conditions
- Opiate Withdrawal Syndrome
- Being tested
- Methadone
- Keywords
- Opiate withdrawal in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
To determine the PK of enteral methadone in children > or = 90 days and <18 years treated for opiate withdrawal per routine medical care.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | > or = 90 days to < 2 years on enteral methadone. Dose schedule is per routine medical care. Receives: Drug: Methadone | |
| Cohort 2 | 2 years to < 6 years on enteral methadone. Dose schedule is per routine medical care. Will include overweight children with BMI for age of 85 - 95 percentile, or obese children BMI for age > or = to 95 percentile. Receives: Drug: Methadone | |
| Cohort 3 | 6 years to < 18 years on enteral methadone. Dose schedule is per routine medical care. Will include overweight children with BMI for age of 85 - 95 percentile, or obese children BMI for age > or = to 95 percentile. Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Parameters after multiple doses of enteral methadone
- Apparent oral clearance
- Apparent oral volume of distribution
- Area under the curve
- Absorption rate constant
Measured: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
Secondary outcomes (7)
PK of methadone's primary metabolite EDDP
Measured: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
PK of R- and S-enantiomers of methadone
Measured: Maximum of 7 PK samples based on dosing schedule collectes over a 5 day period
Correlation between plasma and DBS samples
Measured: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
Correlation between plasma and scavenge samples
Measured: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
Influence of CYP3A4 and CYP3B6 genetic polymorphisms on methadone PK
Measured: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
Methadone pharmacodynamics using the WAT-1
Measured: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
Adverse events
Measured: Study days 1-5 and observational days 6-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin Watt
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Kevin Watt, Duke University
- Investigators
- Kevin watt, MD, Principal investigator, Duke Medical Center/Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945736
- Sponsor's protocol ID
- Pro00044082
- Other IDs
- HHSN27500021
- Acronym
- MTH01
- Status last verified
- Dec 2018
- First submitted
- 16 Sep 2013
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Multiple Dose Methadone in Children
- ClinicalTrials.gov ID
- NCT01945736
- Acronym / sponsor ID
- MTH01 / Pro00044082
- Conditions
- Opiate Withdrawal Syndrome
- Keywords
- Opiate withdrawal in children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kevin WattUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about how the study drug, methadone, prescribed by an infant's or child's physician as part of standard medical care, is processed in children and young adults. While this drug is used extensively in infants and children, it has not been extensively studied in this population.
Physicians do not have very much information on how long it takes for methadone to be removed from the blood circulation and passed out of the body. Physicians need more information to guide how much and how often we should give methadone to children/young adults to ensure they get the maximum effect with the minimum amount of drug. During this research study, the study team will collect information about how this drug is processed in infants and children.
Detailed description
A total of approximately 24 to 36 infants and children will participate in this study. This study will be done at five medical centers in the United States.
Treatment will be prescribed by the infant or child's doctor and not by the study team.
Participants will be divided into 3 groups based on age, ages 3 months to 2 years, ages 2 to 6 years, and ages 6 to 18 years. There will be approximately 8 to 12 participants enrolled in each group. Additionally, at least 6 overweight or obese participants between ages 2-18 years will be included in this study.
Information collected from each subject's routine medical care will include:
- Participant gender, date of birth, race and ethnicity
- Pertinent medical history
- Laboratory results (blood count and chemistries) from routine testing ordered by the infant or child's regular doctor
- Medications of interest the child was given within the 72 hours prior to first dose of methadone administered after consent
- Time and dose of methadone administered to the child up to 14 days prior to enrollment
Study specific information collected will include:
- Blood sample collection to measure level of methadone
- Baseline WAT-1 score (sedation withdrawal assessment of the infant or child used to assess symptoms the child/infant may experience when opioid drugs are discontinued).
The duration of the study will be up to 10 days, comprised of a maximum 5 day treatment period a 5 day observation period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Methadone> or = 90 days to < 2 years on enteral methadone. Dose schedule is per routine medical care. |
| Cohort 2 | – | Drug: Methadone2 years to < 6 years on enteral methadone. Dose schedule is per routine medical care. Will include overweight children with BMI for age of 85 - 95 percentile, or obese children BMI for age > or = to 95 percentile. |
| Cohort 3 | – | Drug: Methadone6 years to < 18 years on enteral methadone. Dose schedule is per routine medical care. Will include overweight children with BMI for age of 85 - 95 percentile, or obese children BMI for age > or = to 95 percentile. |
Who may qualify
- Ages
- 91 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be divided into 3 groups based on age, ages 3 months to 2 years, ages 2 to 6 years, and ages 6 to 18 years. There will be approximately 8 to 12 participants enrolled in each group. Additionally, at least 6 overweight or obese participants between ages 2-18 years will be included in this study.
Key inclusion criteria (3 listed)
- >90 days - < 18 years of age at the time of first dose of study drug
- Receiving enteral methadone as standard of care
- Signed informed consent/HIPAA documents by the parent/legal guardian and assent (if applicable)
Key exclusion criteria (5 listed)
- Previous participation in the study
- Subject is receiving ECLS (Extracorporeal Life Support)
- < 36 weeks gestational age at birth for children <1 year of age at time of enrollment
- Any other condition or chronic illness that in the opinion of the Principal
- Investigator makes participation unadvised or unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethadoneTo determine the PK of enteral methadone in children > or = 90 days and <18 years treated for opiate withdrawal per routine medical care. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
PK Parameters after multiple doses of enteral methadone
Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
* Apparent oral clearance * Apparent oral volume of distribution * Area under the curve * Absorption rate constant
7 secondary outcomes
PK of methadone's primary metabolite EDDP
Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
PK of R- and S-enantiomers of methadone
Time frame: Maximum of 7 PK samples based on dosing schedule collectes over a 5 day period
Correlation between plasma and DBS samples
Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
Correlation between plasma and scavenge samples
Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
Influence of CYP3A4 and CYP3B6 genetic polymorphisms on methadone PK
Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
Methadone pharmacodynamics using the WAT-1
Time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period
Adverse events
Time frame: Study days 1-5 and observational days 6-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
Related trials for Opiate Withdrawal Syndrome
RecruitingPhase 2
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
Opiate Withdrawal Syndrome, Opioid Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin watt, MD principal investigator
Duke Medical Center/Duke Clinical Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiate Withdrawal Syndrome, run by Kevin Watt at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK Parameters after multiple doses of enteral methadone (time frame: Maximum of 7 PK samples based on dosing schedule collected over a 5 day period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.